June 13, 2024
Hello, my name is Laura Lytle. I am the Health Policy Director for the National Center for Health Research (NCHR), a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies, treatments, and products are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
I am grateful for the time today to share NCHR insights on the composition of FDA Advisory Committees. It’s crucial to ensure that these committees are composed of individuals who can provide objective, science-based recommendations. Here are our key areas of concern:
Consumer Representatives: Some consumer representatives lack the necessary scientific expertise to effectively analyze data and critique research design. Additionally, some may have affiliations with industry or products under review, which could lead to conflicts of interest. It’s essential to ensure that consumer representatives truly represent the consumer perspective and possess the required scientific competence. According to FDA guidance, candidates for these positions should meet two criteria: the ability to analyze scientific data and critique research design, and an affiliation with and active participation in independent consumer and community-based organizations, or a history of advocating for the public interest. Many consumer representatives selected would be better suited for positions as patient or industry representatives because they lack the necessary ability to analyze scientific data and critique research design, and many have strong ties to industry or the products they are reviewing. This can lead to conflicts of interest or an inability to make decisions in a scientifically neutral manner.
Financial Conflicts of Interest: The current FDA policy on conflicts of interest is too narrow, allowing individuals with recent financial ties to the industry they are reviewing to serve on Advisory Committees. Transparent disclosure of all financial ties to the company whose product is crucial to maintaining objectivity and trust.
Thank you for your dedication to this important issue and for your time today.